|FDA Allows Marketing of Test to Identify Five Yeast Pathogens; Atossa Offers Regulatory, Commercial Update on ForeCYTE|
|By William Kent|
|Tuesday, 23 September 2014 19:15|
The U.S. Food and Drug Administration allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
Yeast bloodstream infections are a type of fungal infection—they can lead to severe complications and even death if not treated rapidly. These yeast pathogens may cause serious bloodstream infections in people with weakened immune systems, including patients undergoing cancer treatment, receiving immunosuppressive therapy following an organ transplant or severely ill patients in intensive care units.
Traditional methods of detecting yeast pathogens in the bloodstream can require up to six days, and even more time to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours. Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results.
“By testing one blood sample for five yeast pathogens—and getting results within a few hours—physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” said Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.
T2Candida incorporates technologies that break the yeast cells apart, releasing the DNA. It then makes many copies of the target DNA, and detects the amplified DNA using magnetic resonance technology. If yeast DNA is found, T2Candida will also presumptively determine the species category to which it belongs, information that helps to guide health care providers to provide appropriate treatment.
The FDA reviewed T2Candida through its de novo classification process, a regulatory pathway for certain novel low- to moderate-risk medical devices.
FDA based its review on a clinical study of 1,500 patients, in which T2Candida correctly categorized nearly 100 percent of the negative specimens as negative for the presence of yeast.
In a separate clinical study of 300 blood samples with specific concentrations of yeast, T2Candida correctly identified the organism in 84 to 96 percent of the positive specimens.
T2Candida is manufactured by T2 Biosystems, Inc. in Lexington, Mass.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Atossa Genetics Inc. (NASDAQ: ATOS) today announced that the U.S. Food and Drug Administration has issued a determination that the ForeCYTE Breast Aspirator is "not substantially equivalent" to its predicate device. The ForeCYTE Breast Aspirator is, therefore, not cleared by the FDA for marketing in the United States. Atossa plans to now commercialize in the U.S. an alternative breast aspirator, called the FullCYTE Breast Aspirator. The FullCYTE Breast Aspirator is an FDA-cleared device that was acquired by Atossa in 2012 and is a subset of Atossa's FullCYTE Microcather which Atossa has been preparing for commercialization over the past 12 months. Atossa will now prioritize the commercial launch of the FullCYTE Breast Aspirator in the U.S. market.
ForeCYTE Breast Aspirator -- The FDA determined that the ForeCYTE Breast Aspirator did not meet the criteria for substantial equivalence based on data submitted by Atossa. In a letter to Atossa, the FDA provided guidance on additional performance data that Atossa may gather and provide in a potential new 510(k) notification for the device. Atossa intends to request a pre-submission meeting with the FDA to reach agreement on the studies FDA is seeking and then intends to perform those studies and submit a new 510(k) notification for the ForeCYTE Breast Aspirator to the FDA.
Outside the United States, Atossa's commercial strategy is to obtain the CE Mark for its ForeCYTE Breast Aspirator, which it anticipates receiving in the next 30 days, and then in the first quarter of 2015 to launch the device through distributors in select European countries. Atossa is also evaluating Asian markets for this device.
FullCYTE Breast Aspirator -- Based in part on the recent feedback received from FDA on the ForeCYTE submission, Atossa has decided to prioritize commercialization of its FullCYTE Breast Aspirator in the United States. The FullCYTE Breast Aspirator is a 510(k) cleared aspirator intended to obtain nipple aspirate fluid for cytological evaluation and as a means of identifying breast ducts for cannulation with the Atossa FullCYTE Microcatheter.
Atossa acquired the FullCYTE Breast Aspirator and FullCYTE Microcatheter, together with their respective 510(k) clearances and U.S. and foreign patents, in 2012 from Hologic, Inc. and has been in the process of preparing for a potential commercial launch. The aspirator device is comprised of a rigid polycarbonate cup which is placed around the breast nipple. The polycarbonate cup is attached to a user supplied standard syringe, which is used to pull a gentle vacuum to express breast ductal fluid. This fluid can be placed directly into a non-gyn liquid-based cytology fixative for transport to a pathology laboratory. The FullCYTE Breast Aspirator device is intended for single patient use only.
Dr. Steven Quay, CEO and President of Atossa stated, "While we are disappointed in the FDA's decision on the ForeCYTE device, we believe this alternative aspirator can help us reach our commercialization goals without a significant delay. We are highly encouraged that we presently possess an FDA-cleared, patented, commercially viable alternative that will permit us to return to the U.S. market with our FullCYTE Breast Aspirator device. We also remain optimistic that our ForeCYTE device will soon receive the CE Mark and we expect our ForeCYTE device will soon be available for commercial marketability in Europe. Our strategy to commercially launch our devices remains on track and we believe we have the appropriate and compliant solutions to enable us to return to revenue generation in the near future."
Conference Call Information -- Management will host a conference call on Wednesday, September 24, 2014, at 9:00 am Eastern Time to provide a Regulatory and Commercial Update. Following management's formal remarks, there will be a question and answer session.
To listen to the call by phone, interested parties within the U.S. should call (Toll Free):1-866-652-5200. International callers should call 1-412-317-6060. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com.
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced the company will webcast its presentation at the 2014 Leerink Partners Rare Disease Roundtable on Wednesday, October 1, 2014 at 3:10 p.m. EDT.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services and mobile tools for medical groups and health systems, today announced that its More Disruption Please (MDP) Accelerator is now accepting applications.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced the appointment of Roman G. Rubio, M.D., as Senior Vice President and Head of Translational Medicine.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN), today announced that management will participate in the Jefferies Gene Therapy Summit on September 30th in Boston and in the Leerink Rare Disease Roundtable on October 1st in New York.
Bionomics Limited (ASX:BNO) (ADR:BMICY) has acquired the business assets of Prestwick Chemical, based in Strasbourg France. Prestwick is co-located with Bionomics' wholly-owned business Neurofit, and reported revenues for the year to December 2013 of €4.292 million. Bionomics has agreed to pay €270,000 for the assets.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, and Beth Israel Deaconess Medical Center, announced today that they have entered into a collaboration to examine genomic biomarkers in patients with Diffuse Large B-Cell Lymphoma (DLBCL), and use an integrated approach to investigate their association with patient outcome.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today it will report financial results for the fiscal fourth quarter and year ended June 30, 2014, on Thursday, September 25, 2014.
Echo Therapeutics (NASDAQ: ECTE), a medical device company, today announced that, as it believes that its current liquidity is insufficient to fund its needs beyond September 30, 2014, it has suspended its product development, research, manufacturing and clinical programs and operations to conserve its liquidity and capital resources.
Egalet Corporation (Nasdaq:EGLT) today announced an update to the clinical development plan for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.
Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing its proprietary topical foams to address unmet needs in dermatology, with its lead product minocycline foam for the treatment of acne, impetigo and other skin conditions, today announced the closing of its initial public offering.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the Company will hold an Analyst Day on Tuesday, September 30, 2014, from 9:00 a.m. to 11:15 a.m. ET (6:00 a.m. to 8:15 a.m. PT).
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, announced today that the Company was named finalist in two categories for Internationale Textilmaschinen Ausstellung's ("ITMA") Future Materials Awards 2014.
LabStyle Innovations Corp. (OTCQB: DRIO), developer of the Dario™ Diabetes Management Solution, today announced that it has closed a $4.2 million private placement offering consisting of shares of preferred stock and warrants.
Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced that the Company will host a conference call and webcast tomorrow, September 24, 2014 at 8:45 a.m. Eastern time to discuss top-line results from its Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300).
MediciNova, Inc., (Nasdaq:MNOV) a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that, as of September 15, 2014, the ongoing Phase 2b trial of MN-166 (ibudilast) in progressive multiple sclerosis (MS) had enrolled 150 of the 250 subjects planned to be enrolled.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announces that its Sherbrooke plant is now operating at an annualized production capacity of 100 metric tons and customer shipments of Neptune manufactured krill oil products have commenced.
Novavax, Inc. (Nasdaq:NVAX) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 1/2 clinical trial of its H7N9 Avian Influenza VLP Vaccine Candidate (H7N9 VLP) with proprietary adjuvant Matrix-M™.
Novavax, Inc. (Nasdaq:NVAX) announced today that it has executed a contract modification with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) to exercise the option period of its current contract (HHSO100201100012C) for the advanced development of Novavax' recombinant seasonal and pandemic influenza vaccines and manufacturing capabilities for pandemic preparedness.
Pacific Biosciences of California, Inc., (Nasdaq:PACB) provider of the PacBio® RS II DNA Sequencing System, and Macrogen, a global leader in genome sequencing services, announced today that Macrogen has selected the PacBio Single Molecule, Real-Time (SMRT®) Sequencing platform to create high-quality de novo human genome references for the Asian population.
ProQR Therapeutics N.V. (Nasdaq:PRQR) announced today the closing of its initial public offering of 8,625,000 ordinary shares at a public offering price of $13.00 per share, which includes the exercise in full by the underwriters of their option to purchase 1,125,000 additional ordinary shares.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it is accelerating the prototype development of its Firefly Dx system, a handheld, real-time PCR (polymerase chain reaction) system designed to provide molecular diagnostic results in less than 20 minutes at the point of need.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced that company management will present at the Leerink Rare Disease Roundtable in New York on Wednesday, October 1, 2014 at 1:30 p.m. EDT/10:30 a.m. PDT.
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that Vikas Sharma, Ph.D., the Company's Director of Business Development, will present at the 14th Annual Biotech in Europe Investor Forum for Global Partnering and Investment in Basel, Switzerland on Tuesday, September 30, 2014 at 10:00 AM (Central European Time).
Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced the introduction of Oxaliplatin Injection, USP, an antineoplastic agent, now in two liquid presentations.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today reported that it is collaborating with an international consortium to provide an RNAi based investigational therapeutic for expedited clinical studies in West Africa.
TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that it has exercised its option to license the global rights to TGR-1202, the Company's novel, next generation PI3K-delta inhibitor from Rhizen Pharmaceuticals, S A ("Rhizen").
ZS Pharma (Nasdaq:ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced positive top-line results from HARMONIZE (ZS004), its second Phase 3 clinical trial of ZS-9 (sodium zirconium cyclosilicate), a novel investigational treatment for hyperkalemia.